Syringe with Visual Use Indicator

ABSTRACT

Systems and methods are presented for the visual indication of whether a power injector has discharged fluid from a power injector syringe in a previous medical procedure. In this regard, the systems and methods generally provide for a power injector and a syringe for use with the power injector. The syringe includes a visual indicator ( 164 ) that moves between a first state and a second state at approximately the same time that the power injector discharges fluid from the syringe such that an operator may view the change in state.

RELATED APPLICATIONS

This application claims priority to US Provisional Patent ApplicationNo. 61/149,720 filed on 4 Feb. 2009 entitled “SYRINGE WITH VISUAL USEINDICATOR”.

FIELD OF THE INVENTION

The present invention generally relates to the field of syringes and,more particularly, to providing information that fluid may havepreviously been discharged from a syringe.

BACKGROUND

Various medical procedures require that one or more medical fluids beinjected into a patient. For example, medical imaging proceduresoftentimes involve the injection of contrast media into a patient,possibly along with saline or other fluids. Other medical proceduresinvolve injecting one or more fluids into a patient for therapeuticpurposes. Power injectors may be used for these types of applications.

A power injector generally includes what is commonly referred to as apowerhead. One or more syringes may be mounted to the powerhead invarious manners (e.g., detachably; rear-loading; front-loading;side-loading). Each syringe typically includes what may be characterizedas a syringe plunger, piston, or the like. Each such syringe plunger isdesigned to interface with (e.g., contact and/or temporarilyinterconnect with) an appropriate syringe driver that is incorporatedinto the powerhead, such that operation of the syringe driver axiallyadvances the associated syringe plunger inside and relative to a barrelof the syringe. One typical syringe driver is in the form of a ram thatis mounted on a threaded lead or drive screw. Rotation of the drivescrew in one rotational direction advances the associated ram in oneaxial direction, while rotation of the drive screw in the oppositerotational direction advances the associated ram in the opposite axialdirection.

Power injector syringes may be disposable—only used for a singleinjection. If a power injector syringe were to be re-used, it should besterilized before being reloaded with fluid for use in a subsequentinjection.

SUMMARY

As used herein, the phrase “fluidly isolated” or the like describes arelationship between components where fluid is not able to flow betweenthe components. For example, where two components are fluidly isolatedfrom each other, fluid is currently unable to flow from one component tothe other component. Such an inability to flow may be due to one or morevalves being positioned to prevent such flow between the two components.Certain components may at all times be fluidly isolated from each other.

As used herein, the phrases “fluidly interconnected, “in fluidcommunication with,” “fluidly communicates with,” or the like eachdescribes a relationship between components where fluid is currentlyable to flow between the components. Such an inability to flow may bedue to one or more valves being positioned to allow such flow betweenthe two components. Certain components may at all times be in fluidcommunication with each other. For example, “an injection device fluidlyinterconnected to a patient” describes a configuration where fluid isable to flow from the injection device, through any intermediatecomponents (e.g., tubing, connectors), and to the patient (e.g., intothe vasculature of the patient).

A first aspect of the present invention is embodied by a power injectorthat includes a syringe plunger driver and a syringe. The syringeplunger driver includes a plunger interface and a motorized drive sourceoperable to move the plunger interface in multiple directions (e.g., ineach direction along an axial path). The syringe includes an internalfluid discharge chamber, a syringe plunger that is movably disposedwithin this fluid discharge chamber, and a visual indicator member thatis located outside of the fluid discharge chamber (e.g., on an exteriorsurface of the syringe). To discharge the syringe, the syringe plungerdriver interacts with the syringe plunger to move the syringe plunger inat least a first direction. Prior to the advancement of the syringeplunger, the visual indicator member is in a first state, but the visualindicator member is irreversibly changed to a second state in responseto the movement of the syringe plunger by the syringe plunger driver.

A number of feature refinements and additional features are applicableto the first aspect of the present invention. These feature refinementsand additional features may be used individually or in any combination.The following discussion is applicable to the first aspect, up to thestart of the discussion of a second aspect of the present invention.

The syringe may include a syringe body, where the syringe plunger ismovable relative to the syringe body and where at least part of thesyringe plunger (e.g., a plunger head) is disposed within the syringebody. To move the syringe plunger within the syringe body in at least afirst axial direction, the syringe plunger driver may include an axiallymoveable ram, and the plunger interface may move along with the ram. Inturn, the plunger interface interacts with the syringe plunger to moveit in at least one axial direction. The plunger interface may be of anyappropriate size, shape, configuration, and/or type to allow the syringeplunger driver to interact with the syringe plunger in any appropriatemanner to move the syringe plunger in at least one axial direction(e.g., a mechanical coupling, magnetic coupling, etc.).

The visual indicator member may be disposed on an exterior of thesyringe body such that the visual indicator member remains at all timesisolated from any fluid contained within the syringe (e.g., fluid withinthe fluid discharge chamber). For instance, the visual indicator membermay be disposed between the syringe body and a label attached to anexterior of the syringe body. To allow an operator to observe the visualindicator member, the label may include at least one transparent sectionthat coincides with the visual indicator member such that the visualindicator member is visible through the transparent section. Thetransparent section may be a discrete portion of the label or it maycoincide with the entirety of the label, and the transparent section maybe formed of any material that accommodates viewing a visual changethrough the transparent section. For example, the transparent sectionmay be clear or of translucent color so long as an operator may perceivea visual change through the transparent section.

The visual indicator member itself may be in the form of apressure-sensitive material. This pressure-sensitive material mayinclude any material that exhibits an optically detectable response tochanges in pressure (e.g., a pressure-sensitive adhesive, polymer, gel,foam, etc.). For example, the pressure-sensitive material may take theform of a label adhesive, a separate material that is disposed between alabel and the syringe body, or it may be incorporated into the labelitself. When disposed outside of the fluid discharge chamber (e.g., onan exterior of the syringe body), the pressure-sensitive material maychange from a first color to a second color in response to exposure to apressure change. Thus, as the syringe plunger advances in a direction todischarge fluid from the syringe, the pressure within the syringe bodyincreases, thereby causing the pressure-sensitive material to changefrom a first state (e.g., a first color) to a second state (e.g., asecond color).

The visual indicator member could also be in the form of a fluid source.The fluid source may include a first fluid within an enclosure. Thefirst fluid may be any visible indicator fluid (e.g., a colored fluid,for instance a liquid) of an appropriate viscosity that allows theindicator fluid to flow, and the enclosure may be formed of anydeformable, malleable, and/or rupturable material that ruptures uponexposure to at least a certain pressure (e.g., a blister pack).

The visual indicator member may further include a flowpath that isinterconnectable with the fluid source. The flowpath may be configuredsuch that the first fluid and the flowpath are fluidly isolated when thevisual indicator member is in a first state (i.e., before the fluidsource ruptures), but that the first fluid flows within the flowpathwhen the visual indicator member is in a second state (i.e., after thefluid source ruptures). The flowpath may be a channel that is inset intoor fully enclosed within the exterior of the syringe and that recedesfrom the fluid source. The channel may be of any appropriate size,shape, and/or configuration to allow fluid to flow within it along avisible portion of the syringe body (e.g., at least about 10% of alength of the syringe body). In addition, a label may be disposed overthe flowpath (such that the first fluid is contained between the labeland an exterior of the syringe). To allow an operator to observe thevisual indicator member, the label may include at least one transparentsection that coincides with the visual indicator member such that thevisual indicator member is visible through the transparent section. Thetransparent section may be a discrete portion of the label or it maycoincide with the entirety of the label, and the transparent section maybe formed of any material that accommodates viewing a visual changethrough the transparent section. For example, the transparent sectionmay be clear or of translucent color so long as an operator may perceivea visual change through the transparent section.

In one embodiment, the fluid source may be aligned with a moveablemember. This movable member may be incorporated into the structure ofthe syringe. For instance, the moveable member may be a dimple, ahollow, or a depression in the surface of the syringe that may be of anyappropriate size, shape, and/or configuration to receive the fluidsource. In a first position, the moveable member may be convex inrelation to the interior of the syringe and concave in relation to theexterior of the syringe. In a second position, the moveable member maybe convex in relation to the exterior of the syringe and concave inrelation to the interior of the syringe. The moveable member may movebetween the first and second positions, or invert, in response to apressure increase in the interior of the syringe that develops withinthe syringe as the syringe plunger advances in a direction to dischargefluid from the syringe. This inversion, or movement between the firstand second positions, may compress the fluid source between the moveablemember and another structure (e.g., an overlying label), thereby causingthe fluid source to rupture and release the indicator fluid to flow downthe flowpath and serve as a visual indicator that the power injector hasdischarged fluid from the syringe.

In one embodiment, the syringe may be disposed within a pressure jacketthat is configured to restrain the syringe body when the syringe ispressurized. The pressure jacket may be of any appropriate size, shape,configuration, and/or type to fully encompass the syringe body andwithstand a certain amount of outward force from the pressurized syringeso as to prevent the pressurized syringe from rupturing when fullypressurized by the power injector. In this embodiment, the moveablemember may be a deformable, frustumly-shaped section of the syringelocated between a syringe barrel and a discharge port of the syringebody. The fluid source may be disposed upon the frustumly-shaped surfacebetween the exterior surface of the syringe and a corresponding interiorsurface of the pressure jacket. As the syringe plunger driver advancesthe syringe plunger in a direction to discharge fluid from the syringe,the moveable member may deform and/or the syringe may move axiallyrelative to the pressure jacket in response to a pressure increase thatdevelops within the syringe. This deformation and/or syringe movementmay compress the fluid source between the exterior surface of thesyringe and the interior surface of the pressure jacket, which mayrupture the fluid source and release the indicator fluid to flow alongthe flow path.

A second aspect of the present invention is embodied by a power injectorthat includes a syringe plunger driver, a light source, and a syringe.The syringe plunger driver includes a plunger interface and a motorizeddrive source that is operable to move the plunger interface in multipledirections (e.g., in each direction along an axial path). The syringeincludes a syringe plunger and a visual indicator member thatirreversibly changes between a first state and a second state inresponse to the activation of the light source.

A third aspect of the present invention is embodied by a method ofoperation for a power injector. This method includes the steps ofexposing a visual indicator member on a syringe to an output from alight source in order to change the color of the visual indicator, andadvancing a ram to in turn advance a syringe plunger.

A number of feature refinements and additional features are applicableto the second and third aspects of the present invention. These featurerefinements and additional features may be used individually or in anycombination. The following discussion is applicable to the second andthird aspects, up to the start of the discussion of a fourth aspect ofthe present invention.

The light source may be of any appropriate type, and may issue light ofany appropriate wavelength or combination of wavelengths (e.g., ultraviolet (“UV”) light). Operation of the light source could be controlledby the power injector, the light source could be manually activated(e.g., by a clinician), or both. The light source may be incorporated bythe power injector in any appropriate manner. For instance, the powerinjector may include a powerhead of any appropriate size, shape,configuration, and/or type, and the light source could be integratedinto the structure of the powerhead. The light source could also bedetachably mounted to the power injector in any appropriate manner andat any appropriate location. In one embodiment, the light source is ahandheld unit and may be manually operated.

The visual indicator member may be disposed on an exterior of thesyringe such that the visual indicator member remains at all timesfluidly isolated from any fluid contained within the syringe. Forinstance, the visual indicator member may be disposed between thesyringe body and a label. To allow an operator to observe the visualindicator member, the label may include at least one transparent sectionthat coincides with the visual indicator member such that the visualindicator member is visible through the transparent section. Thetransparent section may be a discrete portion of the label or it maycoincide with the entirety of the label, and the transparent section maybe formed of any material that accommodates viewing a visual changethrough the transparent section. For instance, the transparent sectionmay be clear or have a translucent color that allows an operator mayperceive a visual change through the transparent section.

The visual indicator member itself may be formed of any appropriatelight-sensitive material that exhibits an optically detectable responseto exposure to at least certain light (e.g., UV-sensitive adhesives,gels, foams, paints, etc.). For example, the light-sensitive materialmay take the form of a label adhesive, a separate material that isdisposed beneath the label, or it may be incorporated into the structureof the label itself. When disposed on the exterior of the syringe body,the visual indicator member may change from a first color to a secondcolor upon exposure to at least a certain light, thereby providing avisual indication to an operator that the power injector has dischargedfluid from the syringe.

The light exposure may occur either before or after advancement of thesyringe plunger to discharge fluid from the syringe. In addition, anoperator may manually initiate exposure or exposure may be integratedwith an injection or operations protocol such that exposure occursautomatically at the appropriate time.

A fourth aspect of the present invention is embodied by a syringe.Components of the syringe include a syringe body having an interiorsurface and an exterior surface, a syringe plunger moveably disposedwithin the syringe body, a label disposed on the exterior surface of thesyringe body, and a pressure-sensitive material disposed between thelabel and the exterior surface of the syringe body.

A number of feature refinements and additional features are applicableto the fourth aspect of the present invention. These feature refinementsand additional features may be used individually or in any combination.The following discussion is applicable to the fourth aspect, up to thestart of the discussion of a fifth aspect of the present invention.

The syringe plunger may have a proximal end that includes a couplingadapted to interact with a syringe plunger driver of a power injector.The power injector may be any appropriate power injector adapted for usewith a syringe, and the coupling may be of any appropriate size, shape,configuration, and/or type to allow the syringe plunger driver tointeract with the syringe plunger to move the syringe plunger in atleast one direction.

To allow an operator to observe the pressure-sensitive material, thelabel may be disposed on the exterior surface of the syringe body, andfurthermore may include at least one transparent section that coincideswith the pressure-sensitive material such that the material is visiblethrough the transparent section. The transparent section may be adiscrete portion of the label or it may coincide with the entirety ofthe label, and the transparent section may be formed of any materialthat accommodates viewing a visual change through the transparentsection. For instance, the transparent section may be clear or oftranslucent color so long as an operator may perceive a visual changethrough the transparent section.

The pressure-sensitive material itself may be any material that exhibitsan optically detectable response to changes in pressure (e.g., apressure-sensitive adhesive, polymer, gel, foam, etc.). For example, thepressure-sensitive material may take the form of a label adhesive or ofanother, separate material that is disposed beneath the label. Whendisposed between the label and the exterior surface of the syringe body,the pressure-sensitive material may change from a first color to asecond color in response to a pressure change. That is, prior toexposure to at least a first pressure, the pressure-sensitive materialis in a first sate (e.g., a first color), and after exposure to at leasta first pressure, the pressure-sensitive material is irreversiblychanged to a second state (e.g., a second color).

A fifth aspect of the present invention is embodied by a syringe havinga syringe body, which in turn includes an internal fluid dischargechamber. The syringe further includes a syringe plunger that movablydisposed within the syringe body (e.g., within the fluid dischargechamber), a fluid source that is disposed outside of the fluid dischargechamber, and a movable member aligned with the fluid source.

A sixth aspect of the present invention is embodied by a method foroperating a power injector. The method includes the steps of advancing aram to advance a syringe plunger of a syringe, expanding a first portionof the syringe in response to a differential pressure created in thesyringe as the syringe plunger advances, and activating a first visualindicator in response to this expansion of the syringe.

A number of feature refinements and additional features are applicableto the fifth and sixth aspects of the present invention. These featurerefinements and additional features may be used individually or in anycombination.

The first visual indicator may be a fluid source that includes a firstfluid within an enclosure. The first fluid may be any visible indicatorfluid (e.g., a colored liquid, etc.) of an appropriate viscosity thatallows the indicator fluid to flow, and the enclosure may be formed of adeformable, malleable, and/or rupturable material that ruptures uponexposure to at least a certain pressure (e.g., a blister pack).

In addition, the syringe may include a flowpath that is fluidlyinterconnectable with the fluid source. The flowpath may be a channelthat is inset into or fully enclosed on an exterior of the syringe body(e.g., so as to be fluidly isolated from an internal fluid dischargechamber of the syringe) and that extends from the fluid source down avisible portion of the syringe body (e.g., to at least about 10% downthe length of the syringe body). In a first state (i.e., prior to anadvancement of the syringe plunger to discharge fluid from the syringebody), the fluid source and the flowpath may be fluidly isolated, whilein a second state (i.e., the development of a differential pressure inresponse to the advancement of the syringe plunger), the fluid sourcecommunicates with the flowpath. A label may be disposed over each of thefluid source and the channel. The label may include a transparentsection that coincides with at least a portion of the channel. Thetransparent section may be a discrete portion of the label or it maycoincide with the entirety of the label, and the transparent section maybe formed of any material that accommodates viewing a visual changethrough the transparent section. For instance, the transparent sectionmay be clear or of translucent color so long as an operator may perceivea visual change through the transparent section.

In one embodiment, the moveable member may be a dimple, a hollow, or adepression formed in the structure of the syringe. The moveable membermay be of any appropriate size, shape, and/or configuration so as toreceive the fluid source. In a first position and prior to the movementof the syringe plunger to discharge fluid from the syringe, the moveablemember may be convex relative to the interior of the syringe and concaverelative to the exterior of the syringe. As the syringe plunger advancesto discharge fluid from the syringe body, a differential pressuredevelops. In response to this differential pressure, the moveable membermay move from the first position to a second position (e.g., invert)such that the moveable member is now concave relative to the interior ofthe syringe and convex relative to the exterior of the syringe. Theinversion, or movement of the moveable member between the first andsecond positions, may compress the fluid source between the moveablemember and another structure (e.g., a label on an exterior of thesyringe), thereby rupturing the fluid source and releasing the firstfluid to flow along the flowpath where an operator may view theresulting color change through the transparent section of the label andknow that fluid has been discharged fluid from the syringe.

In one embodiment, the syringe may be disposed within a pressure jacketthat is configured to restrain the syringe body when the syringe ispressurized. The pressure jacket may be of any appropriate size, shape,configuration, and/or type to fully encompass the syringe body andwithstand a certain amount of outward force from the pressurized syringeso as to prevent the pressurized syringe from rupturing when fullypressurized. In this embodiment, the moveable member may be adeformable, frustumly-shaped section of the syringe located between asyringe barrel and a discharge port of the syringe body. The fluidsource may coincide with the frustumly-shaped surface between theexterior surface of the syringe body and the pressure jacket.

As the syringe plunger advances to discharge fluid from the syringebody, the deformable section may distort outward and/or the syringe maymove axially relative to the pressure jacket to compress the fluidsource between the exterior surface of the syringe and an interiorsurface of the pressure jacket. As a result, the fluid source ruptures,and the indicator fluid flows down the flowpath where it is visible toan operator through the transparent portion of the label, therebyproviding a visual indication that the power injector has dischargedfluid from the syringe.

A number of feature refinements and additional features are separatelyapplicable to each of above-noted first, second, third, fourth, fifth,and sixth aspects of the present invention. These feature refinementsand additional features may be used individually or in any combinationin relation to each of the above-noted first, second, third, fourth,fifth, and sixth aspects. Any feature of any other various aspects ofthe present invention that is intended to be limited to a “singular”context or the like will be clearly set forth herein by terms such as“only,” “single,” “limited to,” or the like. Merely introducing afeature in accordance with commonly accepted antecedent basis practicedoes not limit the corresponding feature to the singular (e.g.,indicating that a power injector includes “a syringe” alone does notmean that the power injector includes only a single syringe). Moreover,any failure to use phrases such as “at least one” also does not limitthe corresponding feature to the singular (e.g., indicating that a powerinjector includes “a syringe” alone does not mean that the powerinjector includes only a single syringe). Finally, use of the phrase “atleast generally” or the like in relation to a particular featureencompasses the corresponding characteristic and insubstantialvariations thereof (e.g., indicating that a syringe barrel is at leastgenerally cylindrical encompasses the syringe barrel being cylindrical).

Any power injector that may be utilized to provide a fluid discharge maybe of any appropriate size, shape, configuration, and/or type. Any suchpower injector may utilize one or more syringe plunger drivers of anyappropriate size, shape, configuration, and/or type, where each suchsyringe plunger driver is capable of at least bi-directional movement(e.g., a movement in a first direction for discharging fluid; a movementin a second direction for accommodating a loading of fluid or so as toreturn to a position for a subsequent fluid discharge operation), andwhere each such syringe plunger driver may interact with itscorresponding syringe plunger in any appropriate manner (e.g., bymechanical contact; by an appropriate coupling (mechanical orotherwise)) so as to be able to advance the syringe plunger in at leastone direction (e.g., to discharge fluid). Each syringe plunger drivermay utilize one or more drive sources of any appropriate size, shape,configuration, and/or type. Multiple drive source outputs may becombined in any appropriate manner to advance a single syringe plungerat a given time. One or more drive sources may be dedicated to a singlesyringe plunger driver, one or more drive sources may be associated withmultiple syringe plunger drivers (e.g., incorporating a transmission ofsorts to change the output from one syringe plunger to another syringeplunger), or a combination thereof. Representative drive source formsinclude a brushed or brushless electric motor, a hydraulic motor, apneumatic motor, a piezoelectric motor, or a stepper motor.

Any such power injector may be used for any appropriate applicationwhere the delivery of one or more medical fluids is desired, includingwithout limitation any appropriate medical application (e.g., computedtomography or CT imaging; magnetic resonance imaging or MRI; singlephoton emission computed tomography or SPECT imaging; positron emissiontomography or PET imaging; X-ray imaging; angiographic imaging; opticalimaging; ultrasound imaging). Any such power injector may be used inconjunction with any component or combination of components, such as anappropriate imaging system (e.g., a CT scanner). For instance,information could be conveyed between any such power injector and one ormore other components (e.g., scan delay information, injection startsignal, injection rate).

Any appropriate number of syringes may be utilized with any such powerinjector in any appropriate manner (e.g., detachably; front-loaded;rear-loaded; side-loaded), any appropriate medical fluid may bedischarged from a given syringe of any such power injector (e.g.,contrast media, a radiopharmaceutical, saline, and any combinationthereof), and any appropriate fluid may be discharged from a multiplesyringe power injector configuration in any appropriate manner (e.g.,sequentially, simultaneously), or any combination thereof. In oneembodiment, fluid discharged from a syringe by operation of the powerinjector is directed into a conduit (e.g., medical tubing set), wherethis conduit is fluidly interconnected with the syringe in anyappropriate manner and directs fluid to a desired location (e.g., to acatheter that is inserted into a patient, for instance for injection).Multiple syringes may discharge into a common conduit (e.g., forprovision to a single injection site), or one syringe may discharge intoone conduit (e.g., for provision to one injection site), while anothersyringe may discharge into a different conduit (e.g., for provision to adifferent injection site). In one embodiment, each syringe includes asyringe barrel and a plunger that is disposed within and movablerelative to the syringe barrel. This plunger may interface with thepower injector's syringe plunger drive assembly such that the syringeplunger drive assembly is able to advance the plunger in at least onedirection, and possibly in two different, opposite directions.

The syringes disclosed herein may be used with power injectors as noted.However, these syringes may be used with other types of injectiondevices. For instance, these syringes may be used with a hand-held,hand-powered syringe having a pair of levers that are movablyinterconnected (e.g., by a pivot pin), where one lever is also movablyinterconnected with the syringe body (e.g., by a pivot pin), and wherethe other lever is movably interconnected with the plunger (e.g., by apivot pin) such that that a single hand of a user may engage andmanipulate the levers to change the position of the plunger relative tothe syringe body. Although any appropriate pressure could trigger thevisual indication discussed herein, in one embodiment the triggerpressure is of a more elevated level such that these syringes may besuited for fluid delivery devices that are capable of generatingelevated pressures.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a schematic of one embodiment of a power injector.

FIG. 2A is a perspective view of one embodiment of a portablestand-mounted, dual-head power injector.

FIG. 2B is an enlarged, partially exploded, perspective view of apowerhead used by the power injector of FIG. 2A.

FIG. 2C is a schematic of one embodiment of a syringe plunger driveassembly used by the power injector of FIG. 2A.

FIG. 3 is a perspective view of a syringe that utilizes one embodimentof a visual indicator.

FIG. 4A is an exploded perspective view of the syringe of FIG. 3.

FIG. 4B is a cross-sectional view of the syringe of FIG. 3.

FIG. 5A is a perspective view of a syringe that utilizes anotherembodiment of a visual indicator.

FIG. 5B is an exploded perspective view of the syringe of FIG. 5A.

FIG. 5C is a partial, enlarged, cross-sectional view of the syringe ofFIG. 5A in a first state.

FIG. 5D is a detailed view of the fluid source.

FIG. 5E is a partial, enlarged, cross-sectional view of the syringe ofFIG. 5A in a second state.

FIG. 6A is a perspective view of a syringe that utilizes anotherembodiment of a visual indicator, and that is used in conjunction with apressure jacket on a power injector.

FIG. 6B is an exploded perspective view of the syringe of FIG. 6A.

FIG. 6C is a partial, enlarged, cross-sectional view of the syringe ofFIG. 6A in a first state.

FIG. 6D is a detailed view of a portion of the syringe of FIG. 6C.

FIG. 6E is a partial, enlarged, cross-sectional view of the syringe ofFIG. 6A in a second state.

FIG. 7 is a schematic of a syringe for a power injector that utilizesanother embodiment of a visual indicator.

DETAILED DESCRIPTION

FIG. 1 presents a schematic of one embodiment of a power injector 10having a powerhead 12. One or more graphical user interfaces or GUIs 11may be associated with the powerhead 12. Each GUI 11: 1) may be of anyappropriate size, shape, configuration, and/or type; 2) may beoperatively interconnected with the powerhead 12 in any appropriatemanner; 3) may be disposed at any appropriate location; 4) may beconfigured to provide one or any combination of the following functions:controlling one or more aspects of the operation of the power injector10; inputting/editing one or more parameters associated with theoperation of the power injector 10; and displaying appropriateinformation (e.g., associated with the operation of the power injector10); or 5) any combination of the foregoing. Any appropriate number ofGUIs 11 may be utilized. In one embodiment, the power injector 10includes a GUI 11 that is incorporated by a console that is separatefrom but which communicates with the powerhead 12. In anotherembodiment, the power injector 10 includes a GUI 11 that is part of thepowerhead 12. In yet another embodiment, the power injector 10 utilizesone GUI 11 on a separate console that communicates with the powerhead12, and also utilizes another GUI 11 that is on the powerhead 12. EachGUI 11 could provide the same functionality or set of functionalities,or the GUIs 11 may differ in at least some respect in relation to theirrespective functionalities.

A syringe 28 may be installed on this powerhead 12 and, when installed,may be considered to be part of the power injector 10. Some injectionprocedures may result in a relatively high pressure being generatedwithin the syringe 28. In this regard, it may be desirable to disposethe syringe 28 within a pressure jacket 26. The pressure jacket 26 istypically associated with the powerhead 12 in a manner that allows thesyringe 28 to be disposed therein as a part of or after installing thesyringe 28 on the powerhead 12. The same pressure jacket 26 willtypically remain associated with the powerhead 12, as various syringes28 are positioned within and removed from the pressure jacket 26 formultiple injection procedures. The power injector 10 may eliminate thepressure jacket 26 if the power injector 10 is configured/utilized forlow-pressure injections and/or if the syringe(s) 28 to be utilized withthe power injector 10 is (are) of sufficient durability to withstandhigh-pressure injections without the additional support provided by apressure jacket 26. In any case, fluid discharged from the syringe 28may be directed into a conduit 38 of any appropriate size, shape,configuration, and/or type, which may be fluidly interconnected with thesyringe 28 in any appropriate manner, and which may direct fluid to anyappropriate location (e.g., to a patient).

The powerhead 12 includes a syringe plunger drive assembly or syringeplunger driver 14 that interacts (e.g., interfaces) with the syringe 28(e.g., a plunger 32 thereof) to discharge fluid from the syringe 28.This syringe plunger drive assembly 14 includes a drive source 16 (e.g.,a motor of any appropriate size, shape, configuration, and/or type,optional gearing, and the like) that powers a drive output 18 (e.g., arotatable drive screw). A ram 20 may be advanced along an appropriatepath (e.g., axial) by the drive output 18. The ram 20 may include acoupler 22 for interacting or interfacing with a corresponding portionof the syringe 28 in a manner that will be discussed below.

The syringe 28 includes a plunger or piston 32 that is movably disposedwithin a syringe barrel 30 (e.g., for axial reciprocation along an axiscoinciding with the double-headed arrow B). The plunger 32 may include acoupler 34. This syringe plunger coupler 34 may interact or interfacewith the ram coupler 22 to allow the syringe plunger drive assembly 14to retract the syringe plunger 32 within the syringe barrel 30. Thesyringe plunger coupler 34 may be in the form of a shaft 36 a thatextends from a body of the syringe plunger 32, together with a head orbutton 36 b. However, the syringe plunger coupler 34 may be of anyappropriate size, shape, configuration, and/or type.

Generally, the syringe plunger drive assembly 14 of the power injector10 may interact with the syringe plunger 32 of the syringe 28 in anyappropriate manner (e.g., by mechanical contact; by an appropriatecoupling (mechanical or otherwise)) so as to be able to move or advancethe syringe plunger 32 (relative to the syringe barrel 30) in at leastone direction (e.g., to discharge fluid from the corresponding syringe28). That is, although the syringe plunger drive assembly 14 may becapable of bi-directional motion (e.g., via operation of the same drivesource 16), the power injector 10 may be configured such that theoperation of the syringe plunger drive assembly 14 actually only moveseach syringe plunger 32 being used by the power injector 10 in only onedirection. However, the syringe plunger drive assembly 14 may beconfigured to interact with each syringe plunger 32 being used by thepower injector 10 so as to be able to move each such syringe plunger 32in each of two different directions (e.g. in different directions alonga common axial path).

Retraction of the syringe plunger 32 may be utilized to accommodate aloading of fluid into the syringe barrel 30 for a subsequent injectionor discharge, may be utilized to actually draw fluid into the syringebarrel 30 for a subsequent injection or discharge, or for any otherappropriate purpose. Certain configurations may not require that thesyringe plunger drive assembly 14 be able to retract the syringe plunger32, in which case the ram coupler 22 and syringe plunger coupler 34 maynot be desired. In this case, the syringe plunger drive assembly 14 maybe retracted for purposes of executing another fluid delivery operation(e.g., after another pre-filled syringe 28 has been installed). Evenwhen a ram coupler 22 and syringe plunger coupler 34 are utilized, itmay such that these components may or may not be coupled when the ram 20advances the syringe plunger 32 to discharge fluid from the syringe 28(e.g., the ram 20 may simply “push on” the syringe plunger coupler 34 ordirectly on a proximal end of the syringe plunger 32). Any single motionor combination of motions in any appropriate dimension or combination ofdimensions may be utilized to dispose the ram coupler 22 and syringeplunger coupler 34 in a coupled state or condition, to dispose the ramcoupler 22 and syringe plunger coupler 34 in an un-coupled state orcondition, or both.

The syringe 28 may be installed on the powerhead 12 in any appropriatemanner. For instance, the syringe 28 could be configured to be installeddirectly on the powerhead 12. In the illustrated embodiment, a housing24 is appropriately mounted on the powerhead 12 to provide an interfacebetween the syringe 28 and the powerhead 12. This housing 24 may be inthe form of an adapter to which one or more configurations of syringes28 may be installed, and where at least one configuration for a syringe28 could be installed directly on the powerhead 12 without using anysuch adapter. The housing 24 may also be in the form of a faceplate towhich one or more configurations of syringes 28 may be installed. Inthis case, it may be such that a faceplate is required to install asyringe 28 on the powerhead 12—the syringe 28 could not be installed onthe powerhead 12 without the faceplate. When a pressure jacket 26 isbeing used, it may be installed on the powerhead 12 in the variousmanners discussed herein in relation to the syringe 28, and the syringe28 will then thereafter be installed in the pressure jacket 26.

The housing 24 may be mounted on and remain in a fixed position relativeto the powerhead 12 when installing a syringe 28. Another option is tomovably interconnect the housing 24 and the powerhead 12 to accommodateinstalling a syringe 28. For instance, the housing 24 may move within aplane that contains the double-headed arrow A to provide one or more ofcoupled state or condition and an un-coupled state or condition betweenthe ram coupler 22 and the syringe plunger coupler 34.

One particular power injector configuration is illustrated in FIG. 2A,is identified by a reference numeral 40, and is at least generally inaccordance with the power injector 10 of FIG. 1. The power injector 40includes a powerhead 50 that is mounted on a portable stand 48. A pairof syringes 86 a, 86 b for the power injector 40 is mounted on thepowerhead 50. Fluid may be discharged from the syringes 86 a, 86 bduring operation of the power injector 40.

The portable stand 48 may be of any appropriate size, shape,configuration, and/or type. Wheels, rollers, casters, or the like may beutilized to make the stand 48 portable. The powerhead 50 could bemaintained in a fixed position relative to the portable stand 48.However, it may be desirable to allow the position of the powerhead 50to be adjustable relative to the portable stand 48 in at least somemanner. For instance, it may be desirable to have the powerhead 50 inone position relative to the portable stand 48 when loading fluid intoone or more of the syringes 86 a, 86 b, and to have the powerhead 50 ina different position relative to the portable stand 48 for performanceof an injection procedure. In this regard, the powerhead 50 may bemovably interconnected with the portable stand 48 in any appropriatemanner (e.g., such that the powerhead 50 may be pivoted through at leasta certain range of motion, and thereafter maintained in the desiredposition).

It should be appreciated that the powerhead 50 could be supported in anyappropriate manner for providing fluid. For instance, instead of beingmounted on a portable structure, the powerhead 50 could beinterconnected with a support assembly, that in turn is mounted to anappropriate structure (e.g., ceiling, wall, floor). Any support assemblyfor the powerhead 50 may be positionally adjustable in at least somerespect (e.g., by having one or more support sections that may berepositioned relative to one more other support sections), or may bemaintained in a fixed position. Moreover, the powerhead 50 may beintegrated with any such support assembly so as to either be maintainedin a fixed position or so as to be adjustable relative the supportassembly.

The powerhead 50 includes a graphical user interface or GUI 52. This GUI52 may be configured to provide one or any combination of the followingfunctions: controlling one or more aspects of the operation of the powerinjector 40; inputting/editing one or more parameters associated withthe operation of the power injector 40; and displaying appropriateinformation (e.g., associated with the operation of the power injector40). The power injector 40 may also include a console 42 and powerpack46 that each may be in communication with the powerhead 50 in anyappropriate manner (e.g., via one or more cables), that may be placed ona table or mounted on an electronics rack in an examination room or atany other appropriate location, or both. The powerpack 46 may includeone or more of the following and in any appropriate combination: a powersupply for the injector 40; interface circuitry for providingcommunication between the console 42 and powerhead 50; circuitry forpermitting connection of the power injector 40 to remote units such asremote consoles, remote hand or foot control switches, or other originalequipment manufacturer (OEM) remote control connections (e.g., to allowfor the operation of power injector 40 to be synchronized with the x-rayexposure of an imaging system); and any other appropriate componentry.The console 42 may include a touch screen display 44, which in turn mayprovide one or more of the following functions and in any appropriatecombination: allowing an operator to remotely control one or moreaspects of the operation of the power injector 40; allowing an operatorto enter/edit one or more parameters associated with the operation ofthe power injector 40; allowing an operator to specify and storeprograms for automated operation of the power injector 40 (which canlater be automatically executed by the power injector 40 upon initiationby the operator); and displaying any appropriate information relation tothe power injector 40 and including any aspect of its operation.

Various details regarding the integration of the syringes 86 a, 86 bwith the powerhead 50 are presented in FIG. 2B. Each of the syringes 86a, 86 b includes the same general components. The syringe 86 a includesplunger or piston 90 a that is movably disposed within a syringe barrel88 a. Movement of the plunger 90 a along an axis 100 a (FIG. 2A) viaoperation of the powerhead 50 will discharge fluid from within a syringebarrel 88 a through a nozzle 89 a of the syringe 86 a. An appropriateconduit (not shown) will typically be fluidly interconnected with thenozzle 89 a in any appropriate manner to direct fluid to a desiredlocation (e.g., a patient). Similarly, the syringe 86 b includes plungeror piston 90 b that is movably disposed within a syringe barrel 88 b.Movement of the plunger 90 b along an axis 100 b (FIG. 2A) via operationof the powerhead 50 will discharge fluid from within the syringe barrel88 b through a nozzle 89 b of the syringe 86 b. An appropriate conduit(not shown) will typically be fluidly interconnected with the nozzle 89b in any appropriate manner to direct fluid to a desired location (e.g.,a patient).

The syringe 86 a is interconnected with the powerhead 50 via anintermediate faceplate 102 a. This faceplate 102 a includes a cradle 104that supports at least part of the syringe barrel 88 a, and which mayprovide/accommodate any additional functionality or combination offunctionalities. A mounting 82 a is disposed on and is fixed relative tothe powerhead 50 for interfacing with the faceplate 102 a. A ram coupler76 of a ram 74

(FIG. 2C), which are each part of a syringe plunger drive assembly orsyringe plunger driver 56 (FIG. 2C) for the syringe 86 a, is positionedin proximity to the faceplate 102 a when mounted on the powerhead 50.Details regarding the syringe plunger drive assembly 56 will bediscussed in more detail below in relation to FIG. 2C. Generally, theram coupler 76 may be coupled with the syringe plunger 90 a of thesyringe 86 a, and the ram coupler 76 and ram 74 (FIG. 2C) may then bemoved relative to the powerhead 50 to move the syringe plunger 90 aalong the axis 100 a (FIG. 2A). It may be such that the ram coupler 76is engaged with, but not actually coupled to, the syringe plunger 90 awhen moving the syringe plunger 90 a to discharge fluid through thenozzle 89 a of the syringe 86 a.

The faceplate 102 a may be moved at least generally within a plane thatis orthogonal to the axes 100 a, 100 b (associated with movement of thesyringe plungers 90 a, 90 b, respectively, and illustrated in FIG. 2A),both to mount the faceplate 102 a on and remove the faceplate 102 a fromits mounting 82 a on the powerhead 50. The faceplate 102 a may be usedto couple the syringe plunger 90 a with its corresponding ram coupler 76on the powerhead 50. In this regard, the faceplate 102 a includes a pairof handles 106 a. Generally and with the syringe 86 a being initiallypositioned within the faceplate 102 a, the handles 106 a may be moved toin turn move/translate the syringe 86 a at least generally within aplane that is orthogonal to the axes 100 a, 1001) (associated withmovement of the syringe plungers 90 a, 90 b, respectively, andillustrated in FIG. 2A). Moving the handles 106 a to one positionmoves/translates the syringe 86 a (relative to the faceplate 102 a) inan at least generally downward direction to couple its syringe plunger90 a with its corresponding ram coupler 76. Moving the handles 106 a toanother position moves/translates the syringe 86 a (relative to thefaceplate 102 a) in an at least generally upward direction to uncoupleits syringe plunger 90 a from its corresponding ram coupler 76.

The syringe 86 b is interconnected with the powerhead 50 via anintermediate faceplate 102 b. A mounting to 82 b is disposed on and isfixed relative to the powerhead 50 for interfacing with the faceplate102 b. A ram coupler 76 of a ram 74 (FIG. 2C), which are each part of asyringe plunger drive assembly 56 for the syringe 86 b, is positioned inproximity to the faceplate 102 b when mounted to the powerhead 50.Details regarding the syringe plunger drive assembly 56 again will bediscussed in more detail below in relation to FIG. 2C. Generally, theram coupler 76 may be coupled with the syringe plunger 90 b of thesyringe 86 b, and the ram coupler 76 and ram 74 (FIG. 2C) may be movedrelative to the powerhead 50 to move the syringe plunger 90 b along theaxis 100 b (FIG. 2A). It may be such that the ram coupler 76 is engagedwith, but not actually coupled to, the syringe plunger 90 b when movingthe syringe plunger 90 b to discharge fluid through the nozzle 89 b ofthe syringe 86 b.

The faceplate 102 b may be moved at least generally within a plane thatis orthogonal to the axes 100 a, 100 b (associated with movement of thesyringe plungers 90 a, 90 b, respectively, and illustrated in FIG. 2A),both to mount the faceplate 102 b on and remove the faceplate 102 b fromits mounting 82 b on the powerhead 50. The faceplate 102 b also may beused to couple the syringe plunger 90 b with its corresponding ramcoupler 76 on the powerhead 50. In this regard, the faceplate 102 b mayinclude a handle 106 b. Generally and with the syringe 86 b beinginitially positioned within the faceplate 102 b, the syringe 86 b may berotated along its long axis 100 b (FIG. 2A) and relative to thefaceplate 102 b. This rotation may be realized by moving the handle 106b, by grasping and turning the syringe 86 b, or both. In any case, thisrotation moves/translates both the syringe 86 b and the faceplate 102 bat least generally within a plane that is orthogonal to the axes 100 a,100 b (associated with movement of the syringe plungers 90 a, 90 b,respectively, and illustrated in FIG. 2A). Rotating the syringe 86 b inone direction moves/translates the syringe 86 b and faceplate 102 b inan at least generally downward direction to couple the syringe plunger90 b with its corresponding ram coupler 76. Rotating the syringe 86 b inthe opposite direction moves/translates the syringe 86 b and faceplate102 b in an at least generally upward direction to uncouple its syringeplunger 90 b from its corresponding ram coupler 76.

As illustrated in FIG. 2B, the syringe plunger 90 b includes a plungerbody 92 and a syringe plunger coupler 94. This syringe plunger coupler94 includes a shaft 98 that extends from the plunger body 92, along witha head 96 that is spaced from the plunger body 92. Each of the ramcouplers 76 includes a larger slot that is positioned behind a smallerslot on the face of the ram coupler 76. The head 96 of the syringeplunger coupler 94 may be positioned within the larger slot of the ramcoupler 76, and the shaft 98 of the syringe plunger coupler 94 mayextend through the smaller slot on the face of the ram coupler 76 whenthe syringe plunger 90 b and its corresponding ram coupler 76 are in acoupled state or condition. The syringe plunger 90 a may include asimilar syringe plunger coupler 94 for interfacing with itscorresponding ram coupler 76.

The powerhead 50 is utilized to discharge fluid from the syringes 86 a,86 b in the case of the power injector 40. That is, the powerhead 50provides the motive force to discharge fluid from each of the syringes86 a, 86 b. One embodiment of what may be characterized as a syringeplunger drive assembly or syringe plunger driver is illustrated in FIG.2C, is identified by reference numeral 56, and may be utilized by thepowerhead 50 to discharge fluid from each of the syringes 86 a, 86 b. Aseparate syringe plunger drive assembly 56 may be incorporated into thepowerhead 50 for each of the syringes 86 a, 86 b. In this regard andreferring back to FIGS. 2A-B, the powerhead 50 may include hand-operatedknobs 80 a and 80 b for use in separately controlling each of thesyringe plunger drive assemblies 56.

Initially and in relation to the syringe plunger drive assembly 56 ofFIG. 2C, each of its individual components may be of any appropriatesize, shape, configuration and/or type. The syringe plunger driveassembly 56 includes a motor 58, which has an output shaft 60. A drivegear 62 is mounted on and rotates with the output shaft 60 of the motor58. The drive gear 62 is engaged or is at least engageable with a drivengear 64. This driven gear 64 is mounted on and rotates with a drivescrew or shaft 66. The axis about which the drive screw 66 rotates isidentified by reference numeral 68. One or more bearings 72appropriately support the drive screw 66.

A carriage or ram 74 is movably mounted on the drive screw 66.Generally, rotation of the drive screw 66 in one direction axiallyadvances the ram 74 along the drive screw 66 (and thereby along axis 68)in the direction of the corresponding syringe 86 a/b, while rotation ofthe drive screw 66 in the opposite direction axially advances the ram 74along the drive screw 66 (and thereby along axis 68) away from thecorresponding syringe 86 a/b. In this regard, the perimeter of at leastpart of the drive screw 66 includes helical threads 70 that interfacewith at least part of the ram 74. The ram 74 is also movably mountedwithin an appropriate bushing 78 that does not allow the ram 74 torotate during a rotation of the drive screw 66. Therefore, the rotationof the drive screw 66 provides for an axial movement of the ram 74 in adirection determined by the rotational direction of the drive screw 66.

The ram 74 includes a coupler 76 that that may be detachably coupledwith a syringe plunger coupler 94 of the syringe plunger 90 a/b of thecorresponding syringe 86 a/b. When the ram coupler 76 and syringeplunger coupler 94 are appropriately coupled, the syringe plunger 90 a/bmoves along with ram 74. FIG. 2C illustrates a configuration where thesyringe 86 a/b may be moved along its corresponding axis 100 a/b withoutbeing coupled to the ram 74. When the syringe 86 a/b is moved along itscorresponding axis 100 a/b such that the head 96 of its syringe plunger90 a/b is aligned with the ram coupler 76, but with the axes 68 still inthe offset configuration of FIG. 2C, the syringe 86 a/b may betranslated within a plane that is orthogonal to the axis 68 along whichthe ram 74 moves. This establishes a coupled engagement between the ramcoupler 76 and the syringe plunger coupler 96 in the above-noted manner.

The power injectors 10, 40 of FIGS. 1 and 2A-C each may be used for anyappropriate application, including without limitation for medicalimaging applications where fluid is injected into a subject (e.g., apatient). Representative medical imaging applications for the powerinjectors 10, 40 include without limitation computed tomography or CTimaging, magnetic resonance imaging or MRI, single photon emissioncomputed tomography or SPECT imaging, positron emission tomography orPET imaging, X-ray imaging, angiographic imaging, optical imaging, andultrasound imaging. The power injectors 10, 40 each could be used aloneor in combination with one or more other components. The power injectors10, 40 each may be operatively interconnected with one or morecomponents, for instance so that information may be conveyed between thepower injector 10, 40 and one or more other components (e.g., scan delayinformation, injection start signal, injection rate).

Any number of syringes may be utilized by each of the power injectors10, 40, including without limitation single-head configurations (for asingle syringe) and dual-head configurations (for two syringes). In thecase of a multiple syringe configuration, each power injector 10, 40 maydischarge fluid from the various syringes in any appropriate manner andaccording to any timing sequence (e.g., sequential discharges from twoor more syringes, simultaneous discharges from two or more syringes, orany combination thereof). Multiple syringes may discharge into a commonconduit (e.g., for provision to a single injection site), or one syringemay discharge into one conduit (e.g., for provision to one injectionsite), while another syringe may discharge into a different conduit(e.g., for provision to a different injection site). Each such syringeutilized by each of the power injectors 10, 40 may include anyappropriate fluid (e.g., a medical fluid), for instance contrast media,a radiopharmaceutical, saline, and any combination thereof. Each suchsyringe utilized by each of the power injectors 10, 40 may be installedin any appropriate manner (e.g., rear-loading configurations may beutilized; front-loading configurations may be utilized; side-loadingconfigurations may be utilized).

FIGS. 3 and 4A-B illustrate one embodiment of a syringe 110 that may beused in connection with a power injector or any other appropriateinjection device. Hereafter, the syringe 110 will be described inconjunction with the power injector 40 (FIGS. 2A-C), although it shouldbe appreciated that the syringe 110 may be used with any appropriatepower injector (e.g., the power injector 10 of FIG. 1). Generally, thesyringe 110 is adapted to provide a clear visual indication that fluidhas likely been discharged from the syringe 110 in a previous medicalprocedure so as to reduce the potential of syringe 110 being reused.Medical professionals seek to avoid mistakenly reusing syringes, becauseonce a syringe has been discharged in connection with a patient, it maybe unsanitary to reuse that syringe with respect to another patient oreven to reuse it for another medical procedure with respect to the samepatient without first sterilizing the syringe 110.

In this embodiment, syringe 110 includes a syringe body 112 having aninternal fluid discharge chamber 112 a and a nozzle 118. A plunger 114is movably disposed within the syringe body 112 and may include asyringe plunger coupler 116 (e.g., for interacting with an injectiondevice). To discharge fluid through the nozzle 118, the syringe plungercoupler 116 may interact with the syringe plunger drive assembly 56(FIG. 2C) of the power injector 40 (FIGS. 2A-C) so as to advance thesyringe plunger 114 relative to the syringe body 112 (e.g., to advancethe syringe plunger 114 through the fluid discharge chamber 112 a).Using the power injector 40 to discharge the syringe 110 in this mannermay result in a relatively high pressure being generated within thesyringe 110. In this regard, a section of pressure-sensitive material120 may be disposed between an exterior surface 124 of the syringe body112 and a label 122 that is appropriately attached to the exteriorsurface 124 of the syringe body 112 (e.g., such that thepressure-sensitive material 120 is fluidly isolated from the internalfluid discharge chamber 112 a). The pressure-sensitive material 120 maybe in the form of any material that exhibits an optically detectableresponse to changes in pressure (e.g., pressure-sensitive adhesive,polymer, gel, foam, etc.), such that the section of pressure-sensitivematerial 120 moves or changes from a first state to a second state inresponse to any appropriate level of pressurization of the syringe body112. For example, the section of pressure-sensitive material 120 maychange from a first color to a second color when the power injector 40(FIGS. 2A-C) pressurizes the syringe body 112 (e.g., develops aninternal pressure of at least 15 psi within the syringe body 112).

In one embodiment, the label 122 may be of any appropriate size or shapethat is sufficient to fully contain the section of pressure-sensitivematerial 120 between the label 122 and the exterior surface 124 of thesyringe body 112. Specifically, beyond an offset perimeter 126, shown inFIG. 3, the label 122 may affix directly to the exterior surface 124 ofthe syringe body 112 so as to fully contain the section ofpressure-sensitive material 120 beneath the label 122, as shown in FIGS.4A-B. This approach reduces the potential that the section ofpressure-sensitive material 120 will be exposed beyond the edge of thelabel 122. It should be appreciated, however, that some embodiments maynot include the offset perimeter 126. For example, if the section ofpressure-sensitive material 120 includes a pressure-sensitive adhesivethat adheres the label 122 to the exterior surface 124 of the syringebody 112, then the section of pressure-sensitive material 120 may extendbeneath the full area of the label 122.

The label 122 may also include a transparent portion 128 through whichthe section of pressure-sensitive material 120 is visible to an operatorwho may observe the section of pressure-sensitive material 120 bothbefore and after the syringe 110 has been discharged. The transparentportion 128 may be of any appropriate shape or size to maximizevisibility of the pressure-sensitive material 120.

Another embodiment of a syringe 140 for installation on and use with apower injector is illustrated in FIGS. 5A-E. Hereafter, the syringe 140will be described in conjunction with the power injector 40 (FIGS. 2A-C)although it should be appreciated that the syringe 140 may be used withany appropriate power injector (e.g., the power injector 10 of FIG. 1)or any other appropriate injection device. In this embodiment, thesyringe 140 includes a syringe body 142 and a nozzle 146 with afrustumly-shaped or conical transition portion 150 disposed between thesyringe body 142 and the nozzle 146. A moveable dimple 152 is disposedon the conical transition portion 150, such that the moveable dimple 152is convex relative to the inside of the conical transition portion 150(and including in relation to the interior, fluid-containing volume ofthe syringe 140, or an internal fluid discharge chamber 142 a). Inaddition, a channel or groove 156 may be inset into the conicaltransition portion 150 and the syringe body 142 (e.g., the channel 156may be formed on the exterior of the syringe 140, or such that thechannel 156 is otherwise fluidly isolated from the internal fluiddischarge chamber 142 a). The channel 156 recedes from the moveabledimple 152 of the conical transition portion 150 to the syringe body142, and then extends along at least part of the length of the syringebody 142 (e.g., along at least about 10% of the length of the syringebody 142). An enclosed fluid source 158 (e.g., a blister pack) includesan amount of indicator fluid 164 encapsulated within a malleable,deformable, and/or rupturable enclosure 166. The enclosed fluid source158 may be disposed within the moveable dimple 152 and below/underneatha label 148 that is configured to cover or enclose both the enclosedfluid source 158 and the entire length of the channel 156. The enclosure166 may be formed of any appropriate substance that is sufficientlycompliant so as to rupture upon exposure to a certain amount ofpressure.

Like the syringe 110 discussed above, the syringe 140 may interact withthe syringe plunger driver assembly 56 (FIG. 2C) of the power injector40 (FIGS. 2A-C) through a syringe plunger coupler 144 of the syringeplunger 143. When disposed in interacting relation, the syringe plungerdriver assembly 56 (FIG. 2C) may advance the syringe plunger 143relative to the syringe body 142 so as to discharge fluid from thenozzle 146. As the syringe plunger 143 advances, pressure builds withinthe syringe body 142 and inverts the moveable dimple 152 into a positionwhere the dimple 152 may then be concave relative to the inside of theconical transition portion 150 (e.g., the interior of the syringe 140)and convex relative to the exterior of the syringe 140. This movementcompresses the enclosed fluid source 158 between the moveable dimple 152and the label 148 and causes the enclosed fluid source 158 to rupture,thereby releasing the indicator fluid 164 and allowing it to flow alongthe channel 156 from the moveable dimple 152 to a distal end 162 of thechannel 156, as shown in FIGS. 5C and 5E.

In this embodiment, the label 148 may include a transparent portion 149that extends at least from a proximal end 160 of the channel 156 to thedistal end 162 of the channel 156, such that an operator may observethat indicator fluid 164 is present in the channel 156 and know that thesyringe 140 has been previously discharged. To allow for prominentvisual indication, the indicator fluid 164 may be any colored fluid ofan appropriate viscosity that allows the indicator fluid 164 to flowalong the channel 156.

In some instances, it may be unnecessary to dispose the enclosed fluidsource 158 within a moveable dimple 152. In general and as discussedabove with respect to FIG. 1, some injection procedures may result in arelatively high pressure being generated within the syringe. In thisregard, a syringe may be disposed within a pressure jacket that protectsthe syringe from rupturing under pressure. The pressure jacket istypically associated with the powerhead of the power injector in amanner that allows a syringe to be disposed therein as a part of orafter installing the syringe on the powerhead. One of ordinary skill inthe art will understand that, generally, in instances where a pressurejacket is used in connection with the syringe, it may become unnecessaryto dispose the enclosed fluid source or blister pack within a moveabledimple, as discussed above. Instead, the enclosed fluid source may beplaced between the external surface of the syringe and the internalsurface of the pressure jacket. When the syringe is pressurized, itdeforms such that the enclosed fluid source is compressed between theexterior surface of the syringe and the interior surface of the pressurejacket and ruptures, thereby freeing the indicator fluid to flow alongthe channel. Such an embodiment is shown in FIGS. 6A-E.

In greater detail. FIGS. 6A-E illustrate another embodiment of a syringe170 for use with a power injector. Hereafter, the syringe 170 will bedescribed in conjunction with the power injector 40 (FIGS. 2A-C),although it should be appreciated that the syringe 170 may be used withany appropriate power injector (e.g., the power injector 10 of FIG. 1).In this embodiment, the syringe 170 is disposed within a pressure jacket172. The syringe 170 includes a syringe body 174 and a nozzle 176 with afrustumly-shaped or conical transition portion 178 disposed between thesyringe body 174 and the nozzle 176. A channel or groove 182 may beinset into the conical transition portion 178 and the syringe body 174(e.g., the channel 182 may be formed on the exterior of the syringe 170,or such that the channel 182 is otherwise fluidly isolated from aninternal fluid discharge chamber 174 a). The channel 182 extends from aproximal end 192 (e.g., located at approximately a midpoint of theconical transition portion 178) to a distal end 206 (e.g., located atleast about 10% down the length of the syringe body 174). The proximalend 192 of the channel 182 is configured to accommodate the diameter ofan enclosed fluid source 184 (e.g., a blister pack). The enclosed fluidsource 184 includes an amount of indicator fluid 186 encapsulated withina malleable, deformable, and/or rupturable enclosure 188. The enclosedfluid source 184 may be disposed at the proximal end 192 of the channel182 such that it protrudes outward from the channel 182 to fill to thegap 202 between the exterior of the conical transition portion 178 andan inside surface 194 of the pressure jacket 172. A label 190 may bedisposed over the enclosed fluid source 184 and extend over the lengthof the channel 182. As discussed above, the enclosure 188 may be anyappropriate substance that is sufficiently compliant so as to ruptureupon the application of a certain amount of pressure.

Like the syringes 110, 140 discussed above, the syringe 170 may interactwith the syringe plunger driver assembly 56 (FIG. 2C) of the powerinjector 40 (FIGS. 2A-C) through a syringe plunger coupler 196 of asyringe plunger 198. When disposed in interacting relation, the syringeplunger driver assembly 56 (FIG. 2C) advances the syringe plunger 198relative to the syringe body 174 so as to discharge fluid from thenozzle 176. The resulting pressure within the syringe 170 may cause theconical transition portion 178 of the syringe 170 to distort, thesyringe 170 to move axially relative to the pressure jacket 172, orboth, and as a result, the enclosed fluid source 184 is pressed betweenthe exterior of the conical transition portion 178 and an inside surface194 of the pressure jacket 172, thereby rupturing the enclosed fluidsource 184 and releasing the indicator fluid 186 to flow from theproximal end 192 of the channel 182 to a distal end 206 of the channel182, as shown in FIGS. 6C and 6E.

In this embodiment, the label 190 may include a transparent portion 204that extends at least from the proximal end 192 of the channel 182 tothe distal end 206 of the channel 182, such that an operator may observethe indicator fluid 186 present in the channel 182 and know that thesyringe 170 has been previously discharged. To allow for prominentvisual indication, the indicator fluid 186 may be any colored fluid ofan appropriate viscosity that allows the indicator fluid 186 to flowalong the channel 182 once the enclosed fluid source 184 has ruptured.

Another embodiment of a syringe 210 for installation on and use with apower injector is illustrated in FIG. 7. Hereafter, the syringe 210 willbe described in conjunction with the power injector 10 (FIG. 1) althoughit should be appreciated that the syringe 210 may be used with anyappropriate power injector (e.g., the power injector 40 of FIGS. 2A-C).Generally, the visual indicator used by the syringe changes states(e.g., colors) when exposed to light of a certain wavelength or within awavelength range. In one embodiment, an ultraviolet (UV) light source isutilized and the syringe 210 will be discussed with regard to the same.Other light sources may be appropriate.

In the FIG. 7 embodiment, a section of material that is sensitive toultra violet (“UV”) light, or a section of UV-sensitive material 220,may be disposed between an exterior surface 214 of a syringe body 212and a label 222 that is at least partially transparent. The UV-sensitivematerial 220 may be in the form of any material that exhibits anoptically-detectable response to exposure to UV light (e.g.,UV-sensitive adhesives, gels, foams, paints, etc.). For example, thesection of UV-sensitive material 220 may change from a first color to asecond color when exposed to UV light.

To activate the section of UV-sensitive material 220, the powerhead 12(FIG. 1) may incorporate a UV light source 216 in any appropriate mannerthat positions the UV light source 216 in a way that when flashed, thesection of UV-sensitive material 220 on the syringe body 212 is directlyexposed to a stream of UV light 226 (e.g., the light source 216 may befixably or detachably mounted to the powerhead 12 via fasteners, clamps,straps, adhesive, etc.). It should also be appreciated that the UV lightsource 216 may be interconnected with other components of the powerinjector 10 or any other appropriate surface or structure. In oneembodiment, the light source 216 may be a handheld unit. During aninjection procedure, the UV light source 216 may flash before or afterthe power injector discharges fluid from the syringe 170, therebyexposing the section of UV-sensitive material 220 to UV light andcausing it to transition from a first state to a second state (e.g.,from a first color to a second color). In this regard, the UV lightsource 216 may be manually activated or activation may be integratedwith an automatic injection or operations protocol such that thepowerhead 12 controls the UV light source 216 (e.g. control logic mayactivate the light source 112 when the ram 20 is advanced).

In one embodiment, the label 222 may be any appropriate size or shapethat is sufficient to fully contain the section of UV-sensitive material220 between the label 222 and the exterior surface 214 of the syringebody 212. Specifically, beyond an offset perimeter 218, the label 222may affix directly to the exterior surface 214 of the syringe body 212so as to fully contain the section of UV-sensitive material 220 withinthe offset perimeter 218, as shown in FIG. 7. It should be appreciatedthat in other embodiments, the offset perimeter 218 will be unnecessary.For example, in one embodiment, the section of UV-sensitive material 220may be in the form of a label adhesive that has been treated withUV-sensitive additives. In this embodiment, the section of UV-sensitivematerial 220 may span the full area beneath the label 222, which may bepartially or fully transparent to allow some or all of the adhesive toshow through the label 222. If the label 222 is not completelytransparent, it may include at least a transparent portion 224 throughwhich the section of UV-sensitive material 220 is visible to an operatorwho may observe the section of UV-sensitive material 220 both before andafter the syringe 210 is exposed to UV light during an injectionprocedure. The transparent portion 224 may be any appropriate shape orsize to maximize visibility.

The various syringes disclosed herein may be used in conjunction withpower injectors as noted. They may be appropriate for use with otherinjection devices as well. For instance, each of the syringes disclosedherein may be used with the type of hand-held, hand-powered injectors ofthe type disclosed by U.S. Pat. No. 7,041,084, entitled “HAND-HELD, HANDOPERATED POWER SYRINGE AND METHODS,” and that issued on May 9, 2006.

The foregoing description of the present invention has been presentedfor purposes of illustration and description. Furthermore, thedescription is not intended to limit the invention to the form disclosedherein. Consequently, variations and modifications commensurate with theabove teachings, and skill and knowledge of the relevant art, are withinthe scope of the present invention. The embodiments describedhereinabove are further intended to explain best modes known ofpracticing the invention and to enable others skilled in the art toutilize the invention in such, or other embodiments and with variousmodifications required by the particular application(s) or use(s) of thepresent invention. It is intended that the appended claims be construedto include alternative embodiments to the extent permitted by the priorart.

1. A power injector comprising: a syringe plunger driver comprising amotorized drive source and a plunger interface, wherein said plungerinterface is movable in multiple directions by operation of saidmotorized drive source; and a syringe comprising an internal fluiddischarge chamber, a syringe plunger movably disposed within said fluiddischarge chamber, and a visual indicator member disposed outside ofsaid fluid discharge chamber, wherein said syringe plunger driverinteracts with said syringe plunger to move said syringe plunger in atleast a first direction, wherein said visual indicator member is in afirst state prior to movement of said syringe plunger by said syringeplunger driver, and wherein said visual indicator member is irreversiblychanged to a second state in response to movement of said syringeplunger by said syringe plunger driver.
 2. The power injector of claim1, wherein said syringe plunger driver comprises an axially movable ramthat comprises said plunger interface.
 3. The power injector of claim 1,wherein said visual indicator member at all times remains fluidlyisolated from said internal fluid discharge chamber of said syringe. 4.The power injector of claim 1, wherein said syringe comprises a syringebody, wherein said syringe plunger is movably disposed within saidsyringe body, and wherein said visual indicator member interfaces withan exterior of said syringe body.
 5. The power injector of claim 1,further comprising a label attached to said syringe, wherein said visualindicator member is disposed between said label and an exterior of saidsyringe.
 6. The power injector of claim 1, wherein said visual indicatormember comprises a pressure-sensitive material.
 7. The power injector ofclaim 6, wherein said first state for said pressure-sensitive materialis a first color, and wherein said second state for saidpressure-sensitive material is a second color.
 8. The power injector ofclaim 6, wherein said label comprises at least one transparent sectioncoinciding with said pressure-sensitive material.
 9. The power injectorof claim 1, wherein said visual indicator member comprises a fluidsource.
 10. The power injector of claim 9, wherein said fluid sourcecomprises an enclosure and a first fluid within said enclosure.
 11. Thepower injector of claim 10, wherein said first fluid comprises a coloredliquid.
 12. The power injector of claim 10, wherein said enclosure is adeformable member.
 13. The power injector of claim 12, wherein saidenclosure ruptures upon exposure to at least a certain pressure.
 14. Thepower injector of claim 10, wherein said enclosure comprises a blisterpack.
 15. The power injector of claim 10, wherein said visual indicatormember further comprises a flowpath fluidly interconnectable with saidfluid source.
 16. The power injector of claim 15, wherein said fluidsource and said flowpath are fluidly isolated when said visual indicatormember is in said first state, and wherein said fluid sourcecommunicates with said flowpath when said visual indicator member is insaid second state.
 17. The power injector of claim 16, wherein saidsyringe comprises a syringe body, wherein an exterior of said syringebody comprises a channel, and wherein said channel comprises saidflowpath.
 18. The power injector of claim 17, wherein said channelextends at least about 10% of a length of said syringe body.
 19. Thepower injector of claim 17, further comprising a label disposed oversaid channel.
 20. The power injector of claim 9, wherein said syringecomprises a movable member aligned with said fluid source.
 21. The powerinjector of claim 20, wherein said movable member moves from a firstposition to a second position in response to a differential pressurethat develops by advancement of said syringe plunger.
 22. The powerinjector of claim 21, wherein fluid is released from said fluid sourcein response to said movable member moving from said first position tosaid second position.
 23. The power injector of claim 20, whereinmovable member comprises a dimple.
 24. The power injector of claim 23,wherein said dimple inverts in response to movement of said syringeplunger.
 25. The power injector of claim 23, wherein said dimple isconvex on an interior of said syringe and is concave on an exterior ofsaid syringe prior to movement of said syringe plunger in a direction todischarge fluid from said syringe.
 26. The power injector of claim 25,wherein movement of said syringe plunger in a direction to dischargefluid from said syringe inverts said dimple so that said dimple isconcave on said interior of said syringe and is convex on said exteriorof said syringe.
 27. The power injector of claim 23, wherein inversionof said dimple in response to movement of said syringe plunger rupturessaid fluid source.
 28. The power injector of claim 20, wherein saidmovable member comprises a deformable section of said syringe.
 29. Thepower injector of claim 9, wherein said syringe comprises a syringebody, that in turn comprises a barrel and a discharge port, wherein saidfluid source is located between said syringe barrel and said dischargeport.
 30. The power injector of claim 9, further comprising a pressurejacket, wherein said syringe is disposed within said pressure jacket,wherein said syringe comprises a frustumly-shaped surface, and whereinsaid fluid source is disposed between said frustumly-shaped surface ofsaid syringe and said pressure jacket.
 31. The power injector of claim9, wherein said fluid source comprises a colored liquid.
 32. A powerinjector comprising: a syringe plunger driver comprising a motorizeddrive source and a plunger interface, wherein said plunger interface ismovable in multiple directions by operation of said motorized drivesource; a light source; and a syringe comprising a syringe plunger and avisual indicator member, wherein said visual indicator member is in afirst state prior activation of said light source, and wherein saidvisual indicator member is irreversibly changed to a second state inresponse to activation of said light source. 33-39. (canceled)
 40. Asyringe, comprising: a syringe body comprising an interior surface andan exterior surface; a syringe plunger movably disposed within saidsyringe body; a label engaged with said exterior surface of said syringebody; and a pressure-sensitive material disposed between said label andsaid exterior surface of said syringe body. 41-45. (canceled)
 46. Asyringe, comprising: a syringe body comprising an internal fluiddischarge chamber; a syringe plunger movably disposed within saidsyringe body; a fluid source disposed outside of said fluid dischargechamber; and a movable member aligned with said fluid source, whereinsaid movable member moves in response to a pressure within said internalfluid discharge chamber. 47-67. (canceled)
 68. A method of operation fora power injector, comprising: advancing a ram; advancing a syringeplunger of a syringe in response to said advancing a ram step; expandinga first portion of said syringe in response to differential pressureprovided by said advancing a syringe plunger step; and activating afirst visual indicator in response to said expanding step. 69-75.(canceled)
 76. A method of operation for a power injector, comprising:exposing a visual indicator member on a syringe to an output from alight source; changing color of said visual indicator member in responseto set exposing step; advancing a ram; and advancing a syringe plungerof a syringe in response to said advancing a ram step. 77-80. (canceled)